Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

Journal Article (Journal Article;Multicenter Study)

BACKGROUND: Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. METHODS: In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. FINDINGS: Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. INTERPRETATION: Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

Full Text

Duke Authors

Cited Authors

  • Derman, RJ; Kodkany, BS; Goudar, SS; Geller, SE; Naik, VA; Bellad, MB; Patted, SS; Patel, A; Edlavitch, SA; Hartwell, T; Chakraborty, H; Moss, N

Published Date

  • October 7, 2006

Published In

Volume / Issue

  • 368 / 9543

Start / End Page

  • 1248 - 1253

PubMed ID

  • 17027730

Electronic International Standard Serial Number (EISSN)

  • 1474-547X

Digital Object Identifier (DOI)

  • 10.1016/S0140-6736(06)69522-6


  • eng

Conference Location

  • England